Partial Test report - Cryosense€¦ · DEKRA Testing and Certification, S.A.U. Parque Tecnológico...

DEKRA Testing and Certification, S.A.U. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España C.I.F. A29 507 456

Report No: (NIE) 57750REM.001

2018-12-10

Test report No:

NIE: 59276REM.001

Partial Test report EN 60601-1-2 (2015): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

Identification of item tested Class II-A Sanitary Product

Trademark CRYOSENSE-Whole Body Cryotherapy Cabin

Model and /or type reference TCT

Other identification of the product HW Version: 7.2/ Cryosense XL 3.2/ Cryosense MD 1.0 SW Version: 13.0

Features

Cabin size (length x width x height): 1,82 x 0,95 x 2,3m Max Weight: 150 Kg.

Manufacturer TIME-TECNOLOGÍA E INNOVACIÓN MÉDICO-ESTÉTICA, S.L. C/ Isabel Colbrand, 10. Nave 81. 28050. Madrid. Spain.

Test method requested, standard EN 60601-1-2 (2015)

Summary

See results in “Summary” section and Appendix A.

Approved by (name / position & signature) Rafael López EMC Lab Manager

Date of issue 2018-12-10

Report template No FDT08_21


Report No: (NIE) 57750REM.001 Page 2 of 34 2018-08-28

Index Competences and guarantees ...................................................................................................................... 3

General conditions ......................................................................................................................................... 3

Uncertainty ..................................................................................................................................................... 3

Data provided by the client ............................................................................................................................ 4

Usage of samples .......................................................................................................................................... 4

Test sample description ................................................................................................................................. 5

Identification of the client ............................................................................................................................... 6

Testing period and place ............................................................................................................................... 6

Document history ........................................................................................................................................... 6

Environmental conditions .............................................................................................................................. 7

Remarks and comments ................................................................................................................................ 8

Testing verdicts .............................................................................................................................................. 8

Summary ....................................................................................................................................................... 9

Appendix A: Test results ..............................................................................................................................11

Appendix B: Photographs ............................................................................................................................33



Competences and guarantees

DEKRA Testing and Certification is a testing laboratory accredited by the National Accreditation Body (ENAC -Entidad Nacional de Acreditación), to perform the tests indicated in the Certificate No. 51/LE 147.

DEKRA Testing and Certification is a testing laboratory competent to carry out the tests described in this report.

In order to assure the traceability to other national and international laboratories, DEKRA Testing and Certification has a calibration and maintenance program for its measurement equipment.

DEKRA Testing and Certification guarantees the reliability of the data presented in this report, which is the result of the measurements and the tests performed to the item under test on the date and under the conditions stated on the report and, it is based on the knowledge and technical facilities available at DEKRA Testing and Certification at the time of performance of the test.

DEKRA Testing and Certification is liable to the client for the maintenance of the confidentiality of all information related to the item under test and the results of the test.

The results presented in this Test Report apply only to the particular item under test established in this document.

IMPORTANT: No parts of this report may be reproduced or quoted out of context, in any form or by any means, except in full, without the previous written permission of DEKRA Testing and Certification.

General conditions

1. This report is only referred to the item that has undergone the test.

2. This report does not constitute or imply on its own an approval of the product by the Certification Bodies or competent Authorities.

3. This document is only valid if complete; no partial reproduction can be made without previous written permission of DEKRA Testing and Certification.

4. This test report cannot be used partially or in full for publicity and/or promotional purposes without previous written permission of DEKRA Testing and Certification and the Accreditation Bodies.

Uncertainty Uncertainty (factor k=2) was calculated according to the DEKRA Testing and Certification internal document PODT000. The total uncertainty of the measurement system for the measured conducted disturbance characteristics of EUT from 150 kHz to 30 MHz is I = ± 3,9 dB for quasi-peak measurements, I = ± 3,2 dB for peak measurements (k = 2).

The total uncertainty of the measurement system for the measured radio disturbance characteristics of EUT from 30 MHz to 1000 MHz is I = ± 5 dB for quasi-peak measurements, I = ± 4,7 dB for peak measurements (k = 2).

The total uncertainty of the measurement system for the measured radio disturbance characteristics of EUT from 1 to 6GHz is I=± 4,2 dB for peak & average measurements (k = 2).

The total uncertainty of the measurement system for the harmonic current measurement, is: Current Harmonics: Intensity = ± 0,73% Voltage Harmonics: Voltage = ± 0,58% Confidence level: k=2.

The total uncertainty of the measurement system for the voltage fluctuations and flicker measurement is: Pst Meter: I = ± 0,58% Plt Meter: I = ± 0,58% Idc = 0,58% Idmax = 0,58% Confidence level: k=2.



Data provided by the client Cryosense cabins consist on three main compartments and different moving parts inside. The first compartment is the place where the customer can enter inside through a door and a lifting platform. The second part is the “cabinet” where the mechanical components exist. The purpose of the cabin is giving pulsed air injection to the first compartment. The air is then cooled due to nitrogen action.

DEKRA declines any responsibility with respect to the information provided by the client and that may affect the validity of results.

Usage of samples

Samples under test have been selected by: The client.

Sample S/01 is composed of the following elements:

Control Nº Description Model Serial Nº Date of reception

59276/001 Cryotherapy equipment

CRYOSENSE-Whole Body Cryotherapy Cabin. TCT. Prototype 2018-11-08

59276/002 Storage for Cryotherapy equipment

CRYOSENSE-Whole Body Cryotherapy Cabin. TCT. Prototype 2018-11-08



Test sample description Ports………………………………. :

Port name and description

Cable

Specified length [m]

Attached during test

Shielded

N/A

N/A

N/A

N/A

N/A

N/A

Supplementary information to the ports………………………………. :

N/A

Rated power supply .................... : Voltage and Frequency

Reference poles

L1 L2 L3 N PE

AC: 230Vac.

AC of positioner:

DC:

DC:

Rated Power ............................... : Not provided data

Clock frequencies ....................... : Not provided data

Other parameters ........................ : Not provided data

Software version ......................... : 13.0

Hardware version ........................ : 7.2/ Cryosense XL 3.2/ Cryosense MD 1.0

Dimensions in cm (L x W x D) .... : 1,82 x 0,95 x 2,3 m. Max Weight: 150kg.

Mounting position ........................ : Table top equipment

Wall/Ceiling mounted equipment

Floor standing equipment

Hand-held equipment

Other:

Modules/parts ............................. : Module/parts of test item Type Manufacturer

N/A

N/A

N/A

N/A



Accessories (not part of the test item) ............................................ :

Description Type Manufacturer

N/A

N/A

N/A

N/A

Documents as provided by the applicant ...................................... :

Description File name Issue date

N/A

N/A

N/A

N/A

Identification of the client

Testing period and place

Test Location DEKRA Testing and Certification S.A.U.

Date (start) 2018-11-12

Date (finish) 2018-11-14

Document history

Report number Date Description

59276REM.001 2018-12-10 First release

TIME-TECNOLOGÍA E INNOVACIÓN MÉDICO-ESTÉTICA, S.L. Calle Isabel Colbrand, 10. Nave 81. 28050. Madrid. España.



Environmental conditions

In the control chamber, the following limits were not exceeded during the test:

Temperature Min. = 15 ºC Max. = 35 ºC

Relative humidity Min. = 30 % Max. = 75 %

Air pressure Min. = 860 mbar Max. = 1060 mbar

In the semianechoic chamber, the following limits were not exceeded during the test.

Temperature Min. = 15 ºC Max. = 35 ºC



In the chamber for conducted measurements, the following limits were not exceeded during the test:

Temperature Min. = 15 ºC

Max. = 35 ºC





Remarks and comments The tests have been performed by the technical personnel: Daniel López, Miguel Quesada, Lorena Oviedo & Victoria Olmedo.

Testing verdicts

Not applicable : N/A

Pass : P

Fail : F

Not measured : N/M



Summary

Emission Test

Requirement – Test case Verdict Remark

Radiated emission test (EN 55011) Pass -

Conducted emission test (EN 55011) Pass -

Discontinuous disturbance (clicks) on AC power leads (EN 55014) Pass -

Harmonic current emissions (EN 61000-3-2) N/A *1

Voltage changes, voltage fluctuations and flicker (EN 61000-3-3) N/A *2

Supplementary information and remarks:

*1: The equipment overcomes the 16A per phase in a cycle stage, and therefore, according to section 7.2.1 in

EN 60601-1-2 (2015), this test is not applicable. The client declares in the user manual a nominal power of 3,5kW and therefore, according to section 7 in EN 61000-3-2 and considering that the equipment is declared as Class A “Professional equipment”, this standard has not limits for this equipment type. Measured only as reference.

*2: The equipment overcomes the 16A per phase in a cycle stage, and therefore, according to section 7.2.2 in

EN 60601-1-2 (2015), this test is not applicable. Measured only as reference.

Immunity test

Requirement – Test case Verdict Remark

Radiated electromagnetic fields immunity test (EN 61000-4-3) N/M *3

Conducted electromagnetic fields immunity test on power leads (EN 61000-4-6) Pass -

Fast transients (EN 61000-4-4) Pass -

Surges (EN 61000-4-5) Pass -

Voltage dips and short interruptions (EN 61000-4-11) Pass -

Power frequency magnetic fields (EN 61000-4-8) N/M *3

Electrostatic discharge (EN 61000-4-2) N/M *3

Supplementary information and remarks:

*3: Test not performed. See results in report 57750REM001.



List of equipment used during the test CONTROL

NUMBER DESCRIPTION MANUFACTURER MODEL

CALIBRATION

(LAST/NEXT)

2942 EMI Test Receiver ROHDE & SCHWARZ ESU40 2018-03-14/ 2020-06-19

4578 Bilog Antenna ETS LINDGREN 3142E 2017-04-03/ 2020-04-03

4612 Horn Antenna SCHWARZBECK BBHA 9120 D 2016-12-19/ 2019-12-19

3783 Preamplifier BONN ELEKTRONIK BLMA 0118-3A 2018-05-03/ 2019-03-28

4656 Horn Antenna SCHWARZBECK BBHA 9170 2017-03-24/ 2020-03-24

4570 Thermohigrometer HW GROUP HWg-STE 2018-04-25/ 2019-04-03

4567 Thermohigrometer HW GROUP HWg-STE 2018-04-25/ 2019-04-04

4522 EMC measurement software ROHDE & SCHWARZ EMC32 V10.20 N/A

6121 Preamplifier BONN ELEKTRONIK BLNA 0160-01N 2018-07-19/ 2019-03-20

4729 Preamplifier BONN ELEKTRONIK BLMA 1840-1M 2017-12-02/ 2020-02-23

1650 Artificial network SCHWARZBECK NNLK8121 2017-09-20/ 2019-09-20

5881 Signal Generator KEYSIGHT TECHNOLOGIES N5173B 2016-08-23/

2018-08-23 0753 Power meter ROHDE & SCHWARZ URV5 N/A

3541 Hybrid Bilog Antenna SUNOL SCIENCES CORPORATION JB6 2015-09-07/

2018-09-07 6192 Preamplifier ROHDE AND SCHWARZ BBA150 N/A 6227 Amplifier ROHDE AND SCHWARZ BBA150 N/A 6234 Power Meter ROHDE AND SCHWARZ NRP2 N/A

6236 Amplifier ROHDE AND SCHWARZ BBA150-BC250D110+E100 N/A

6237 Amplifier ROHDE AND SCHWARZ BBA150-A2500 N/A

0870 Current Injection Probe

SOLAR ELECTRONICS COMPANY 9144-1N 2017-06-30 /

2019-06-30 3889 Amplifier AMPLIFIER RESEARCH 75A400 N/A 0921 Signal Generator ROHDE AND SCHWARZ SME03 N/A

5775 Attenuator BIRD 100-A-FFN-06 2018-04-13 / 2020-04-13

4430 Power supply CALIFORNIA INSTRUMENTS MX30-3Pi 2018-05-24 /

2020-05-24

4431 Artificial network CALIFORNIA INSTRUMENTS OMNI 3-75-230 2018-01-19 /

2020-01-19

4225 Harmonics and Flikers analyzer YOKOGAWA 760303 2018-01-18 /

2020-01-18

3598 Power supply EM TEST UCS 500N7 2018-01-23 / 2020-01-23

4432 Coupling Decoupling network EM TEST CNI503B7 2017-02-06 /

2019-02-06

4454 3 Phase AC Switch TESEQ NSG 2200-3 2017-02-10 / 2019-02-10

1456 Magnetic Field Loop Antenna SCHAFFNER --- 2018-04-20 /

2020-04-20

6238 Electrostatic Discharge Simulator EM TEST esd NX30.1 2017-09-26 /

2018-09-26



Appendix A: Test results



Appendix A context

DESCRIPTION OF THE OPERATION MODES ........................................................................ 13

FAILS CRITERIA FOR IMMUNITY TEST ................................................................................. 14

MONITORING FOR IMMUNITY TEST ...................................................................................... 15

CONDUCTED EMISSION. HARMONIC CURRENT MEASUREMENT ..................................... 16

CONDUCTED EMISSION. VOLTAGE FLUCTUATIONS AND FLICKER MEASUREMENT ..... 20

CONTINUOUS CONDUCTED EMISSION ON POWER LEADS ............................................... 22

DISCONTINUOUS CONDUCTED EMISSION ON POWER LEADS ......................................... 25

RADIATED EMISSION. ELECTROMAGNETIC FIELD MEASURE ........................................... 26

IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RF FIELDS ......................... 29

ELECTRICAL FAST TRANSIENT / BURST IMMUNITY TEST ................................................. 30

SURGE INMUNITY TEST ......................................................................................................... 31

VOLTAGE DIPS, SHORT INTERRUPTIONS AND VOLTAGE VARIATIONS TEST ................. 32



DESCRIPTION OF THE OPERATION MODES The operation modes described in this paragraph constitute a functionality of the sample under test for itself. Every operation mode takes a failure criteria for the immunity test that they were applying to it and a monitoring to guarantee performance of the same ones.

The operation modes used by the samples to which the present report refers, are shown in the following table:

OPERATION MODE

DESCRIPTION

OM#01 EUT ON. Equipment performing the “Continuous Cycle” treatment. WiFi connected.

Power supply: 230Vac.



FAILS CRITERIA FOR IMMUNITY TEST

IMMUNITY pass/fail criteria EN 60601-1-2 (2015):

The following list of degradations, that were not allowed with regard to the BASIC SAFETY and ESSENTIAL PERFORMANCE in response to the electromagnetic test signal, is intended as general examples. The MANUFACTURER of the ME EQUIPMENT or ME SYSTEM is required to specify specific IMMUNITY pass/fail criteria for the ME EQUIPMENT or ME SYSTEM under test before the test is performed.

General examples

The following are examples that can be used to develop pass/fail criteria. For ME EQUIPMENT and ME SYSTEMS with multiple functions, the pass/fail criteria should be applied to each function, parameter and channel.

Examples of test failures: - malfunction; - non-operation when operation is required; - unwanted operation when no operation is required; - deviation from normal operation that poses an unacceptable RISK to the PATIENT or OPERATOR; - component failures; - change in programmable parameters; - reset to factory defaults (MANUFACTURER’s presets); - change of operating mode; - a FALSE POSITIVE ALARM CONDITION; - a FALSE NEGATIVE ALARM CONDITION (failure to alarm); - cessation or interruption of any intended operation, even if accompanied by an ALARM SIGNAL; - initiation of any unintended operation, including unintended or uncontrolled motion, even if accompanied by an

ALARM SIGNAL; - error of a displayed numerical value sufficiently large to affect diagnosis or treatment; - noise on a waveform in which the noise would interfere with diagnosis, treatment or monitoring; - artefact or distortion in an image in which the artefact would interfere with diagnosis, treatment or monitoring; - failure of automatic diagnosis or treatment ME EQUIPMENT or ME SYSTEM to diagnose or treat, even if

accompanied by an ALARM SIGNAL. Example of performance during and after the applied testing stimulus required to pass the test:

- for a mammography system, the compression full release and associated command remains fully operational; - for ULTRASOUND DIAGNOSTIC EQUIPMENT, the probe heating, dissipative power and temperature shall

remain within specifications; - safety-related functions perform as intended; - false operation of alarms, “fail safe” modes and similar functions do not occur.

NOTE This might require performing the test twice – once to ensure the functions occur as expected and again to ensure they do not occur falsely.

Examples of acceptable degradation:

- an imaging system displays an image that could be altered, but in a way that would not affect the diagnosis or treatment;

- a heart rate monitor displays a heart rate that could be in error, but by an amount that is not clinically significant;

- a PATIENT monitor exhibits a small amount of noise or a transient on a waveform and the noise or transient would not affect diagnosis, treatment or monitoring.



Examples of ME EQUIPMENT and ME SYSTEMS with multiple functions: multi-parameter monitors;

- anesthesia system with monitors; - ventilators with monitors; - multiple instances of the same function (e.g. multiple invasive blood pressure sensors).

Failure of therapy equipment to terminate a treatment at the intended time can be considered cessation or interruption of an intended operation related to ESSENTIAL PERFORMANCE. If the effect of the test signal on an ME EQUIPMENT or ME SYSTEM is so brief as to be transparent to the PATIENT or OPERATOR and does not affect diagnosis, monitoring or treatment of the PATIENT, this can be considered not to be cessation or interruption of an intended operation. For example, if in response to the IMMUNITY TEST LEVEL a ventilator stops pumping for 50 ms and then resumes operation such that accuracy is within acceptable limits, this would not be considered cessation or interruption of an intended operation.

Note that it might be necessary to test the ME EQUIPMENT or ME SYSTEM multiple times, e.g. under one set of conditions to assure that it sounds an ALARM SIGNAL when it should, within the MANUFACTURER’s specifications for sensitivity and response time, and under another set of conditions to assure that it does not sound an ALARM SIGNAL when it should not.

Example of IMMUNITY pass/fail criteria for a radiological table system. Before, during, and after the IMMUNITY tests, the radiological table system provides freedom from unacceptable RISK. This IMMUNITY pass/fail criteria determination example is an output of the RISK ANALYSIS.

MONITORING FOR IMMUNITY TEST

For every operation mode, the monitoring performed over the samples under test is shown in the following table:

OPERATION MODE

CONTINUOUS PHENOMENA MONITORING

TRANSIENT PHENOMENA MONITORING

OM#01

It is monitored that the equipment remains working correctly according to the selected treatment. Undesired status changes or performance fails in the intended performance are not allowed. Wi-Fi connection is monitored. The device has to maintain the ESSENTIAL PERFORMANCE and the BASIS SAFETY during and after the test.

It is monitored that the equipment remains working correctly according to the selected treatment. Undesired status changes or performance fails in the intended performance are not allowed. WiFi connection is monitored. The device has to maintain the ESSENTIAL PERFORMANCE and the BASIS SAFETY during and after the test.



CONDUCTED EMISSION. HARMONIC CURRENT MEASUREMENT

LIMITS: Product Standard: EN 60601-1-2 (2015)

Test Standard: EN 61000-3-2 (2014)

Class A:

ODDS HARMONICS EVENS HARMONICS

HARMONIC ORDER

MAXIMUM CURRENT (A)

HARMONIC ORDER

MAXIMUM CURRENT (A)

2 1.08 3 2.30 4 0.43 5 1.14 6 0.30 7 0.77

8 ≤ n ≤ 40 0.23*8/n 9 0.40 11 0.33 13 0.21

15 ≤ n ≤ 39 0.15*15/n

TESTED SAMPLES: S/01

OPERATION MODES TESTED: OM#01

TEST RESULTS: CCmmnnAF: CC, Conduction condition; mm: Sample nº; nn:

Operation mode; AF: Test code, Fluctuating harmonics.

CCmmnnAF DESCRIPTION RESULT

CC0101AF

The equipment overcomes the 16A per phase in a cycle stage, and therefore, according to section 7.2.1 in EN 60601-1-2 (2015), this test is not applicable. The client declares in the user manual a nominal power of 3,5kW and therefore, according to section 7 in EN 61000-3-2 and considering that the equipment is declared as Class A “Professional equipment”, this standard has not limits for this equipment type.

N/A*

*Results are shown below as reference



CC0101AF

Harmonics – Class-A per Ed. 4.0 (2014) incl. inter-harmonics

Test category: Class-A per Ed. 4.0 (2014) (European limits) Test Margin: 100 Test date: 11/12/2018 Start time: 14:27:27 End time: 14:32:49 Test duration (min): 5 Data file name: H-000779.cts_data Comment: S/01 OM#01 Test Result: Pass Source qualification: Normal Current & voltage waveforms

Harmonics and Class A limit line European Limits

Test result: Pass Worst harmonic was #13 with 81.5% of the limit.

-30

-20

-10

0

10

20

30

-300

-200

-100

0

100

200

300

Curr

ent (A

mps)

Volta

ge (V

olts)

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Curr

ent R

MS

(Am

ps)

Harmonic #4 8 12 16 20 24 28 32 36 40



CC0101AF (cont.)

Current Test Result Summary (Replay)

Test category: Class-A per Ed. 4.0 (2014) (European limits) Test Margin: 100 Test date: 11/12/2018 Start time: 14:27:27 End time: 14:32:49 Test duration (min): 5 Data file name: H-000779.cts_data Comment: S/01 OM#01 Test Result: Pass Source qualification: Normal THC(A): 0.880 I-THD(%): 20.9 POHC(A): 0.068 POHC Limit(A): 0.251 Highest parameter values during test: V_RMS (Volts): 230.28 Frequency(Hz): 50.00 I_Peak (Amps): 27.604 I_RMS (Amps): 17.206 I_Fund (Amps): 16.843 Crest Factor: 4.365 Power (Watts): 3840.1 Power Factor: 1.000 Harm#Harms(avg)100%Limit %of Limit Harms(max) 150%Limit %of Limit Status 2 0.027 1.080 2.5 0.111 1.620 6.8 Pass 3 0.496 2.300 21.6 0.616 3.450 17.8 Pass 4 0.012 0.430 2.7 0.066 0.645 10.3 Pass 5 0.379 1.140 33.2 0.500 1.710 29.3 Pass 6 0.010 0.300 3.3 0.039 0.450 8.7 Pass 7 0.379 0.770 49.2 0.486 1.155 42.0 Pass 8 0.009 0.230 N/A 0.031 0.345 N/A Pass 9 0.309 0.400 77.1 0.396 0.600 65.9 Pass 10 0.011 0.184 6.2 0.024 0.276 8.6 Pass 11 0.259 0.330 78.3 0.328 0.495 66.2 Pass 12 0.012 0.153 7.7 0.021 0.230 9.1 Pass 13 0.203 0.210 96.9 0.257 0.315 81.5 Pass 14 0.009 0.131 N/A 0.017 0.197 N/A Pass 15 0.139 0.150 92.8 0.175 0.225 78.0 Pass 16 0.008 0.115 N/A 0.015 0.173 N/A Pass 17 0.094 0.132 71.5 0.118 0.198 59.7 Pass 18 0.007 0.102 N/A 0.013 0.153 N/A Pass 19 0.053 0.118 44.6 0.066 0.178 36.9 Pass 20 0.006 0.092 N/A 0.012 0.138 N/A Pass 21 0.022 0.107 20.5 0.033 0.161 20.3 Pass 22 0.006 0.084 N/A 0.012 0.125 N/A Pass 23 0.020 0.098 20.6 0.029 0.147 19.4 Pass 24 0.005 0.077 N/A 0.010 0.115 N/A Pass 25 0.030 0.090 33.3 0.042 0.135 31.2 Pass 26 0.004 0.071 N/A 0.010 0.107 N/A Pass 27 0.032 0.083 39.0 0.041 0.125 33.2 Pass 28 0.003 0.066 N/A 0.009 0.099 N/A Pass 29 0.028 0.078 35.8 0.035 0.116 30.1 Pass 30 0.003 0.061 N/A 0.009 0.092 N/A Pass 31 0.025 0.073 34.4 0.032 0.109 29.7 Pass 32 0.003 0.058 N/A 0.008 0.086 N/A Pass 33 0.015 0.068 22.4 0.022 0.102 21.6 Pass 34 0.003 0.054 N/A 0.008 0.081 N/A Pass 35 0.008 0.064 N/A 0.014 0.096 N/A Pass 36 0.003 0.051 N/A 0.008 0.077 N/A Pass 37 0.009 0.061 N/A 0.017 0.091 N/A Pass 38 0.003 0.048 N/A 0.008 0.073 N/A Pass 39 0.015 0.058 25.3 0.021 0.087 24.0 Pass 40 0.003 0.046 N/A 0.009 0.069 N/A Pass



CC0101AF (cont.)

Voltage Source Verification Data (Replay)

Test category: Class-A per Ed. 4.0 (2014) (European limits) Test Margin: 100 Test date: 11/12/2018 Start time: 14:27:27 End time: 14:32:49 Test duration (min): 5 Data file name: H-000779.cts_data Comment: S/01 OM#01 Test Result: Pass Source qualification: Normal Highest parameter values during test: Voltage (Vrms): 230.28 Frequency(Hz): 50.00 I_Peak (Amps): 27.604 I_RMS (Amps): 17.206 I_Fund (Amps): 16.843 Crest Factor: 4.365 Power (Watts): 3840.1 Power Factor: 1.000 Harm# Harmonics V-rms Limit V-rms % of Limit Status 2 0.060 0.460 13.06 OK 3 0.450 2.049 21.95 OK 4 0.044 0.455 9.65 OK 5 0.229 0.920 24.86 OK 6 0.018 0.456 4.01 OK 7 0.145 0.690 21.04 OK 8 0.016 0.460 3.45 OK 9 0.146 0.460 31.73 OK 10 0.016 0.460 3.45 OK 11 0.145 0.230 63.03 OK 12 0.016 0.228 6.95 OK 13 0.127 0.230 55.11 OK 14 0.016 0.230 6.80 OK 15 0.105 0.230 45.82 OK 16 0.014 0.230 5.92 OK 17 0.085 0.230 37.08 OK 18 0.014 0.230 6.06 OK 19 0.064 0.230 27.97 OK 20 0.013 0.228 5.65 OK 21 0.040 0.230 17.44 OK 22 0.013 0.228 5.73 OK 23 0.029 0.230 12.64 OK 24 0.009 0.230 3.70 OK 25 0.030 0.228 13.30 OK 26 0.006 0.229 2.78 OK 27 0.033 0.228 14.58 OK 28 0.009 0.228 3.99 OK 29 0.032 0.230 13.79 OK 30 0.010 0.228 4.60 OK 31 0.036 0.230 15.46 OK 32 0.008 0.228 3.30 OK 33 0.028 0.230 12.09 OK 34 0.005 0.230 2.02 OK 35 0.023 0.230 9.89 OK 36 0.010 0.228 4.29 OK 37 0.014 0.230 5.99 OK 38 0.009 0.228 3.84 OK 39 0.017 0.230 7.24 OK 40 0.008 0.228 3.53 OK



CONDUCTED EMISSION. VOLTAGE FLUCTUATIONS AND FLICKER MEASUREMENT

LIMITS: Product standard: EN 60601-1-2 (2015)

Test standard: EN 61000-3-3 (2013)

Pst < 1 Short duration flicker indicator Plt < 0,65 Long duration flicker indicator Dc ≤ 3,3% Relative steady-state voltage variation

Dmax ≤ 4% Maximum relative voltage variation

d(t) ≤ 3,3% For a duration of 500ms


OPERATION MODES TESTED: OM#01

TEST RESULTS: CCmmnnFK: CC, Conducted Condition; mm: Sample number; nn:

Operation mode; FK: Flicker test code.

CCmmnnFK DESCRIPTION RESULT

CC0101FK The equipment overcomes the 16A per phase in a cycle stage, and therefore, according to section 7.2.2 in EN 60601-1-2 (2015), this test is not applicable.

N/A*

*Results are shown below as reference



CC0101FK

Flicker Test Summary per EN/IEC61000-3-3 Ed. 3.0 (2013) (Run time)

Test category: All parameters (European limits) Test Margin: 100 Test date: 12/11/2018 Start time: 14:50:46 End time: 16:52:57 Test duration (min): 120 Data file name: F-000781.cts_data Comment: S/01 OM#01 Test Result: Pass Status: Test Completed Psti and limit line European Limits

Plt and limit line

Parameter values recorded during the test: Vrms at the end of test (Volt):228.14 Highest dt (%): -0.95 Test limit (%): N/A N/A T-max (mS): 0 Test limit (mS): 500.0 Pass Highest dc (%): -0.99 Test limit (%): 3.30 Pass Highest dmax (%): -1.01 Test limit (%): 4.00 Pass Highest Pst (10 min. period): 0.350 Test limit: 1.000 Pass Highest Plt (2 hr. period): 0.256 Test limit: 0.650 Pass

0.25

0.50

0.75

1.00

Pst

15:0

1:1

7

15:1

1:2

6

15:2

1:3

5

15:3

1:4

4

15:4

1:5

3

15:5

2:0

2

16:0

2:1

1

16:1

2:2

0

16:2

2:2

9

16:3

2:3

8

16:4

2:4

7

16:5

2:5

6

0.3

0.4

0.5

0.6

Plt

16:5

2:5

6



CONTINUOUS CONDUCTED EMISSION ON POWER LEADS


Test standard: EN 55011 (2016) / A1 (2017)

Limits EN 55011 (2016) / A1 (2017) for Group 1 Class A Main Ports:

Frequency range (MHz)

Limit (dBµV)

Quasi-peak Average 0.15 to 0.5 79 66 0.5 to 30 73 60


TESTED OPERATION MODES: OM#01

TEST RESULTS: CCmmnnhh: CC, Conducted Condition; mm: Sample

number; nn: Operation mode; hh: wire

CCmmnnhh DESCRIPTION RESULT

CC01010N Range: 150kHz – 30MHz. Neutral wire noise. P CC0101L1 Range: 150kHz – 30MHz. Phase wire noise. P



Continuous Conducted Emission: CC01010N

Project: 59276REM.001 Company: TECNOLOGÍA E INNOVACIÓN MÉDICO ESTÉTICA S.L Sample: S/01 Operation mode: OM#01 Description: EUT ON. Team performing Continuous Cycle.WiFi ON. Power

supply: 230Vac. Neutral wire noise

EN 55011 Group 1 Class A

Subrange Maxima

Frequency (MHz)

MaxPeak-ClearWrite (dBµV)

Average-ClearWrite (dBµV)

0.166000 74.5 65.4

0.330000 71.6 64.7

0.494000 57.9 48.5

0.738000 44.6 30.9

1.814000 34.6 24.4

3.386000 48.0 30.0

3.634000 48.0 34.0

10.386000 42.9 27.6

12.378000 40.7 26.4

29.962000 34.8 22.1

0

10

20

30

40

50

60

70

80

150k 300 400 500 800 1M 2M 3M 4M 5M 6 8 10M 20M 30M

Leve

l in

dBµ

V

Frequency in Hz

Peak Scan Average ScanEC EN55011 Group 1 Class A QP EC EN55011 Group 1 Class A AVG

EC EN55011 Group 1 Class A QP

EC EN55011 Group 1 Class A AVG



Continuous Conducted Emission: CC0101L1

Project: 59276REM.001 Company: TECNOLOGÍA E INNOVACIÓN MÉDICO ESTÉTICA S.L Sample: S/01 Operation mode: OM#01 Description: EUT ON. Team performing Continuous Cycle.WiFi ON. Power

supply: 230Vac. Phase wire noise

EN 55011 Group 1 Class A

Subrange Maxima

Frequency (MHz)

MaxPeak-ClearWrite (dBµV)

Average-ClearWrite (dBµV)

0.166000 76.2 65.9

0.334000 71.1 63.6

0.498000 58.0 50.0

0.746000 43.1 31.6

1.746000 36.7 26.3

3.498000 45.2 30.2

3.922000 49.4 38.7

10.162000 43.4 29.1

10.414000 43.6 28.7

29.266000 39.7 25.9

0

10

20

30

40

50

60

70

80

150k 300 400 500 800 1M 2M 3M 4M 5M 6 8 10M 20M 30M

Leve

l in

dBµ

V

Frequency in Hz

Peak Scan Average ScanEC EN55011 Group 1 Class A QP EC EN55011 Group 1 Class A AVG

EC EN55011 Group 1 Class A QP

EC EN55011 Group 1 Class A AVG



DISCONTINUOUS CONDUCTED EMISSION ON POWER LEADS


Test standard: EN 55014-1 (2006) / A1 (2009) / A2 (2011)

Limits for mains ports:

FRECUENCY CUASI-PEAK LIMITS (dBµV)

150 kHz 79 500 kHz 73 1,4 MHz 73 30 MHz 73



TEST RESULTS: CCmmnnhh: CC, Conducted Condition; mm: Sample

number; nn: Operation mode; hh: wire

CCmmnnhh DESCRIPTION RESULT

CC01010N Neutral wire noise (worst case). No clicks detected. P



RADIATED EMISSION. ELECTROMAGNETIC FIELD MEASURE


Test standard: EN 55011 (2016) / AC (2017)

Limits for EN 55011 (2016) / A1 (2017) Class A:

Frequency range (MHz)

Measured field limit at 10 m (dBµV/m) Quasi-Peak measurement

30 to 230 40 230 to 1000 47

TESTED SAMPLES: S/01 TESTED OPERATION MODES: OM#01

TEST RESULTS: CRmmnn: CR, Radiated condition; mm: Sample number; nn:

Operation mode; RR: Measured range.

CRmmnnRR DESCRIPTION RESULT

CR0101 Range: 30 MHz - 1000 MHz. P



Radiated Emission: CR0101

Project: 59276REM.001 Company: Tecnología e Innovación Sample: S/01 Operation mode: OM#01 Description: EUT ON. Team performing Continuous Cycle.WiFi ON. 230 Vac

power.

Full Spectrum

10

20

30 40

50

60

70 76,8

30M 50 60 80 100M 200 300 400 500 800 1G

Leve

l in

dBµ

V/m

Frequency in Hz

Peak Preview QuasiPeakER EN55011 Group 1 Class A MaxPeak

ER EN55011 Group 1 Class A



Radiated Emission: CR0101 (Cont)

Maximizations Frequency

(MHz) QuasiPeak (dBµV/m)

MaxPeak (dBµV/m)

Height (cm)

Pol Azimuth (deg)

31.177000 19.63 53.74 223.0 H 343.0

37.885000 17.18 23.93 333.0 H 301.0

48.006000 25.07 28.90 292.0 H 235.0

64.028000 34.96 37.30 391.0 H 266.0

67.492000 25.27 28.73 114.0 V -1.0

85.052000 25.54 28.93 400.0 H 299.0

89.948000 24.37 27.94 374.0 H 88.0

91.421000 26.97 31.22 400.0 H 282.0

94.038000 29.25 32.96 381.0 H 282.0

98.870000 22.35 28.00 352.0 H 64.0

107.116000 26.58 31.09 304.0 H 253.0

108.837000 23.72 28.84 287.0 H 279.0

110.531000 26.47 30.53 309.0 H 119.0

121.206000 23.94 28.32 115.0 V 136.0

140.367000 27.03 30.43 400.0 V 187.0

144.670000 35.51 38.89 232.0 H 104.0

147.225000 30.60 33.92 286.0 H 127.0

148.146000 30.06 33.82 218.0 H 126.0

159.339000 28.84 31.32 356.0 V 108.0

175.235000 31.13 33.76 318.0 V 177.0

193.773000 28.40 31.19 100.0 V 149.0

197.473000 27.92 30.51 111.0 V 295.0

199.696000 30.11 32.49 104.0 V 300.0

204.116000 27.76 30.74 275.0 V 213.0

206.371000 28.76 31.58 260.0 V 212.0

206.460000 29.59 32.36 283.0 V 203.0

206.884000 30.13 32.48 285.0 V 211.0

207.991000 30.06 33.17 276.0 V 14.0

209.464000 30.70 33.34 292.0 V 212.0

216.343000 25.94 29.15 356.0 V 10.0

222.748000 36.06 47.37 147.0 H 302.0

297.000000 44.68 45.86 252.0 V 345.0

341.587000 27.97 37.63 100.0 H 204.0

371.237000 38.99 50.01 296.0 H 103.0

389.261000 20.62 27.45 296.0 H 96.0

440.594000 19.62 26.90 150.0 V 90.0

552.735000 19.10 27.13 382.0 H 61.0

566.429000 18.95 26.27 248.0 H 322.0

631.359000 18.98 26.98 311.0 V 80.0

860.442000 22.62 30.12 400.0 V 219.0

898.624000 22.91 31.15 215.0 V 196.0



IMMUNITY TO CONDUCTED DISTURBANCES, INDUCED BY RADIOFREQUENCY FIELDS



RANGE FREQUENCY MODULATION STEP LEVEL

A 150 kHz - 80 MHz AM 1 kHz 80% 1% 3 Vrms

B*

6,765 MHz-6,795MHz;

13,553MHz- 13,567MHz;

26,957MHz-27,283MHz;

40,66MHz - 40,70MHz

AM 1 kHz 80% 1% 6 Vrms

* ISM Bands.



FAIL CRITERIA AND MONITORING: A

ZONES/COUPLING CABLES (CPL):

CPL DESCRIPTION

1 AC power supply input 2 Ethernet cable

TEST RESULTS:

CPL RANGE S/ OM# COMMENTS RESULT

1 A 01 01 Ok, no fails detected P 1 B 01 01 Ok, no fails detected P 2 A 01 01 Ok, no fails detected P 2 B 01 01 Ok, no fails detected P



ELECTRICAL FAST TRANSIENT / BURST IMMUNITY TEST



TYPE APPLICATION LEVEL(kV) REPETITION RATE(kHz)

1 AC Power Supply Line ±2kV 5kHz & 100kHz 2 Communication Lines ±1kV 5kHz & 100kHz



FAIL CRITERIA AND MONITORING: B


CPL DESCRIPTION TYPE

A AC power supply line (N = Neutral wire) 1 B AC power supply line (L1 = Phase wire) 1 C AC power supply line (P.E = Ground) 1 D Ethernet cable 2

TEST RESULTS:

CPL S/ OM# COMMENTS RESULT

A 01 01 Ok, no fails detected P B 01 01 Ok, no fails detected P C 01 01 Ok, no fails detected P D 01 01 Ok, no fails detected P



SURGE INMUNITY TEST



TYPE APPLICATION LEVEL (kV) SYMMETRICAL

COUPLING LEVEL (kV) ASYMMETRICAL

COUPLING

1 AC Power Supply ± 0.5 kV; ± 1 kV ± 0.5 kV; ± 1 kV; ± 2 kV




CPL DESCRIPTION TYPE

A Single phase AC power supply line. Symmetrical: L1→N. 1 B Single phase AC power supply line. Asymmetrical on L1: L1→PE. 1 C Single phase AC power supply line. Asymmetrical on N: N→PE. 1

TEST RESULTS:

CPL S/ OM# COMMENTS RESULT

A 01 01 Ok, no fails detected P B 01 01 Ok, no fails detected P C 01 01 Ok, no fails detected P



VOLTAGE DIPS, SHORT INTERRUPTIONS AND VOLTAGE VARIATIONS IMMUNITY TEST



Immunity levels for voltage interruptions:

TEST SEVERITY LEVEL

A 100% during 5 s

Immunity levels for voltage dips and variations:

TEST SEVERITY LEVEL

B 100% during 10 ms C 100% during 20 ms D 30% during 500 ms



FAIL CRITERIA AND MONITORING: According to standard


TEST S/ OM# COMMENTS RESULT

A 01 01 EUT shutdowns during the test and successfully recovers after it. P

B 01 01 OK, no fails detected. P C 01 01 OK, no fails detected. P

D 01 01 The EUT changes its acoustic noise during the disturbances but it continues working without any warning.

P



Appendix B: Photographs



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